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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01135953

Registration number

NCT01135953

Ethics application status

Date submitted

2/06/2010

Date registered

3/06/2010

Date last updated

8/12/2010

Titles & IDs

Public title

Methods to Enhance Transcranial Direct Stimulation (tDCS)

Scientific title

Investigating Methods to Enhance the Excitatory Effects of Transcranial Direct Stimulation (tDCS)

Secondary ID [1]

HREC09344

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Healthy Volunteers

Brain Excitation

Condition category

Condition code

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Treatment: Devices - Transcranial Direct Current Stimulation (tDCS)
Treatment: Devices - Transcranial Direct Current Stimulation (tDCS)
Other interventions - Transcranial direct Stimulation (tDCS) and D-cycloserine

Experimental: ARM 1 - CONTROL - Subject given tDCS every day of the week (5 sessions) at 2 mA.

Experimental: Arm 2 - INCREASING - Subjects given increasing intensity during tDCS across the week (Monday 1mA, Tuesday 1.5mA, Wednesday 1.5 mA, Thursday 2 mA, Friday 2mA).

Experimental: ARM 3 - CYCLOSERINE - D-cycloserine (100 mg) given on the Monday and Thursday sessions, administering tDCS at 2 mA.

Treatment: Devices: Transcranial Direct Current Stimulation (tDCS)
tDCS applied to to motor cortex every weekday (5 sessions), at 2mA ,during 20 minutes.Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).

Treatment: Devices: Transcranial Direct Current Stimulation (tDCS)
tDCS applied to the motor cortex every day of the week during 20 minutes, at 1mA first session, 1.5 mA second and third sessions, and 2mA fourth and fifth sessions, during 20 minutes. Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased over 30 seconds (to avoid the sensation of a flash).

Other interventions: Transcranial direct Stimulation (tDCS) and D-cycloserine
Transcranial Direct Stimulation applied to the motor cortex every day of the week (5 sessions) at 2mA, during 20 minutes. Conductive rubber electrodes (7 x 5 cm = 35 cm2) covered by sponges soaked in saline will be used, held in place by a band. The current will be gradually increased to the level of 2 mA over 30 seconds (to avoid the sensation of a flash).

D-cycloserine, administered orally (capsules), 100 mg, twice a week (Monday and Thursday), prior to the tDCS session.

Intervention code [1]

Treatment: Devices

Intervention code [2]

Other interventions

Comparator / control treatment

Control group

Outcomes

Primary outcome [1]

Change from baseline in brain excitability measured through motor evoked potentials (MEP) 0 to 120 minutes after tDCS session.

Timepoint [1]

Pre-treatment, post treatment at minute 0, minute 5, minute 10, minute 15, minute 20, minute 25, minute 30, minute 60, minute 90, minute 120.

Eligibility

Key inclusion criteria

* Male
* Right handed (> 18/20 on the Edinburgh Handedness)
* Aged 18-40

Minimum age

18 Years

Maximum age

40 Years

Sex

Males

Can healthy volunteers participate?

Yes

Key exclusion criteria

* Mental illness
* General medical illness
* Neurological illness, epilepsy
* Alcohol use above National Health and Medical Research Council (NHMRC) guidelines
* Smokers
* Excessive caffeine intake
* Illicit drug use
* Herbal medication use
* Electronic implant, e.g, cochlear implant, pacemaker
* Musculoskeletal problem in the arm

Study design

Purpose of the study

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people receiving the treatment/s

Intervention assignment

Crossover

Other design features

Phase

Type of endpoint/s

Statistical methods / analysis

Recruitment

Recruitment status

Completed

Data analysis

Reason for early stopping/withdrawal

Other reasons

Date of first participant enrolment

Anticipated

Actual

1/01/2010

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

1/07/2010

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

NSW

Recruitment hospital [1]

Black Dog Institute, University of New South Wales - Sydney

Recruitment postcode(s) [1]

2031 - Sydney

Funding & Sponsors

Primary sponsor type

Other

Name

The University of New South Wales

Address

Country

Ethics approval

Ethics application status

Summary

Brief summary

tDCS has been shown to be an effective treatment for depression. However, tDCS is a relatively new clinical tool and more needs to be understood about its use. This study hopes to further the field of knowledge by examining how tDCS should be optimally used. Application of tDCS in clinical trials of depression is typically to the prefrontal cortex, but in this project, tDCS application will be to the motor cortex as it provides a more ready measure of excitability. Excitability will be measured using Transcranial Magnetic Stimulation (TMS) to the motor cortex and electromyography (EMG) recordings from peripheral muscles stimulated. Using a cross-over three-arm design this study aims to investigate whether daily tDCS administered in increasing intensity across sessions leads to greater and lasting effects on brain excitability than keeping the intensity at a same dose across the days and whether the excitatory effect could be enhanced with D-cycloserine, a medication known to prolong the excitatory effects of a single session of tDCS. This in turn will inform on how to optimize tDCS for therapeutic applications, e.g treatment of depression. The study hypothesis is that 5 sessions of tDCS with a dose of D-cycloserine given on the Monday and Thursday sessions will result in more sustained effect on motor cortex excitability than 5 sessions of tDCS alone. The second hypothesis is that the gradational increases in tDCS intensity over 5 sessions will result in greater motor cortex excitability than 5 sessions of tDCS where intensity is kept constant across sessions.

Trial website

https://clinicaltrials.gov/study/NCT01135953

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Address

Country

Phone

Fax

Contact person for public queries

Name

Address

Country

Phone

Fax

Contact person for scientific queries

No information has been provided regarding IPD availability

What supporting documents are/will be available?

No Supporting Document Provided

Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT01135953

Trial Review

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT01135953